DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL

K061990 · Dade Behring, Inc. · DCF · Sep 19, 2006 · Immunology

Device Facts

• Record ID: K061990
• Device Name: DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL
• Applicant: Dade Behring, Inc.
• Product Code: DCF · Immunology
• Decision Date: Sep 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease. Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista™ System. Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.

Device Story

The Dimension Vista MALB Flex reagent cartridge is an in vitro diagnostic reagent used on the Dimension Vista System to measure albumin in human urine. The device utilizes particle-enhanced immunonephelometry; human urine samples are reacted with specific antibodies to form immune complexes. A beam of light is passed through the sample, and the intensity of scattered light is measured, which is proportional to the albumin concentration. Results are calculated by comparing the sample signal against a known standard. The system is operated by laboratory personnel in a clinical setting. The Protein 3 Calibrator is used to calibrate the assay, and the Protein 3 Control is used to monitor precision and analytical bias. The output provides quantitative albumin levels, assisting clinicians in diagnosing kidney and intestinal diseases.

Clinical Evidence

Method comparison study performed comparing the Dimension Vista MALB assay to the Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec System. Urine samples with concentrations ranging from 5.87 to 332.74 mg/L were evaluated. Regression analysis was conducted to demonstrate equivalence.

Technological Characteristics

The device utilizes particle-enhanced immunonephelometry for the quantitative determination of albumin. The system is an automated clinical chemistry analyzer. The calibrator is a lyophilized, polygeline-based product containing human urinary proteins. The control is a lyophilized, polygeline and albumin-based product containing human albumin.

Indications for Use

Indicated for the quantitative determination of albumin in human urine to aid in the diagnosis of kidney and intestinal disease. Used by clinical laboratory professionals on the Dimension Vista System.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Predicate Devices

• Dade Behring N Antiserum to Human Albumin Assay (k860894)
• Dade Behring N Protein Standard SL (k012470)
• Dade Behring N/T Protein Control LC (k991704)

Submission Summary (Full Text)

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# 510(k) Summary for Dimension Vista™ MALB Flex® reagent cartridge Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

SEP 1 9 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

| Manufacturer: | Dade Behring Marburg GmbH |
|---------------|---------------------------|
| | Emil-von-Behring Str. 76 |
| | D-35001 |
| | Marburg, Germany |

Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]

Preparation date: July 11, 2006

- Dimension Vista™ Microalbumin Flex® reagent cartridge (MALB) 2. Device Name: Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

| Classification: | Class II; Class II; Class I |
|-----------------|---------------------------------------------|
| Product Code: | DCF; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |

#### 3. ldentification of the Legally Marketed Device:

Dade Behring N Antiserum to Human Albumin - K860894 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control LC - K991704

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#### 4. Device Description:

### Dimension Vista™ MALB Flex® reagent cartridge

Proteins contained in human urine form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of albumin in the sample. The result is evaluated by comparison with a standard of known concentration.

### Dimension Vista™ Protein 3 Calibrator

PROT3 CAL is a lyophilized, polygeline based (with urinary proteins of human origin) product containing Albumin.

### Dimension Vista™ Protein 3 Control

PROT3 CON is a lyophilized, polygeline and albumin based product containing albumin of human origin.

#### 5. Device Intended Use:

### Dimension Vista 1 MALB Flex® reagent cartridge:

The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of Albumin aids in the diagnosis of kidney and intestinal disease.

### Dimension Vista™ Protein 3 Calibrator:

Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista " System.

### Dimension Vista™ Protein 3 Control:

Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.

#### 6. Medical device to which equivalence is claimed and comparison information:

The Dimension Vista™ MALB Flex reagent cartridge. Dimension Vista™ Protein 3 Calibrator and Dimension Vista™ Protein 3 Control are substantially equivalent to the Dade Behring N Antiserum to Human Albumin assay (K860894) assay, N Protein Standard SL (K012470) and N/T Protein Control LC (K991704), respectively. The Dimension Vista™ MALB assay, like the Dade Behring N Antiserum to Human Albumin assay is an in vitro diagnostic reagent for the quantitative measurement of Microalbumin (MALB) in human urine by means of particle enhanced immunonephelometry.

#### 7. Device Performance Characteristics:

The Dimension Vista™ MALB assay was compared to the Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 5.87 to 332.74 mg/L. Regression analysis of these results yielded the following equation:

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### Method Comparison Study

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 9 2006

Ms. Kathleen Dray-Lyons Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714-6101

k061990 Re:

> Trade/Device Name: Dimension Vista™ MALB Flex® reagent cartridge Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: DCF, JIT, JJY Dated: July 11, 2006 Received: July 13, 2006

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health_

Enclosure

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Dade Behring Inc. Dimension Vista™ MALB 510(k) Notification

# Indications Statement

### Dimension Vista™ MALB Flex® reagent cartridge Device Name: Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

Indications for Use:

## Dimension Vista™ MALB Flex® reagent cartridge:

The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease.

## Dimension Vista™ Protein 3 Calibrator:

Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista™ System.

## Dimension Vista™ Protein 3 Control:

Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CAC

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) k061990

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